HR20013 for Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents

NCT06554184 | Completed Phase 3

• 1 other identifier: HR20013-302
• Study Type: interventional
• Target: 706
• Locations: 1 country
• Sites: 1

Brief Summary

This study is aimed to evaluate the efficacy and safety of HR20013 versus palonosetron for nausea and vomiting associated with moderate emetic risk anticancer agents

Conditions

Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents

Outcome Measures

Primary Outcomes (1)

• Complete response rate in the delayed phase

  To compare the rate of subjects achieving complete response (defined as no emetic episode and no need for rescue medication) in the delayed phase after initiation of moderate emetic risk anticancer agents.

  24-120 hours after initiation of moderate emetic risk anticancer agents

Secondary Outcomes (11)

• Complete response rate in the overall phase.

  0 - 120 hours after initiation of moderate emetic risk anticancer agents

• Complete response rate in the acute phase.

  0-24 hours after initiation of moderate emetic risk anticancer agents

• Proportion of subjects with no significant nausea (maximum nausea on a visual analogue scale<25 mm)

  the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively

• Proportion of subjects with no nausea (maximum nausea on a visual analogue scale<5 mm)

  the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively

• Proportion of subjects with no emetic

  the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively

Study Arms (2)

HR20013 + dexamethasone + palonosetron placebo

EXPERIMENTAL

Drug: HR20013 + dexamethasone + palonosetron placebo

Palonosetron + dexamethasone + HR20013 placebo

ACTIVE COMPARATOR

Drug: Palonosetron + dexamethasone + HR20013 placebo

Interventions

HR20013 + dexamethasone + palonosetron placebo DRUG

HR20013 + dexamethasone + palonosetron placebo

HR20013 + dexamethasone + palonosetron placebo

Palonosetron + dexamethasone + HR20013 placebo DRUG

Palonosetron + dexamethasone + HR20013 placebo

Palonosetron + dexamethasone + HR20013 placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older, of either gender
• Has a histologically or cytologically confirmed malignant disease
• Naïve to cytotoxic chemotherapy
• Scheduled to receive first course of moderate emetic risk anticancer agents
• Predicted life expectancy of ≥ 3 months
• Has a performance status (ECOG scale) of 0 to 1
• Adequate organ function
• female subjects of childbearing potential must have a negative blood pregnancy test within 72 hours before randomization; and must be non-lactating;
• Able and willing to provide a written informed consent

You may not qualify if:

• Received or planned to receive total body irradiation, or radiation therapy to the abdomen, pelvis, Whole brain and spinal cord, head and neck , or chest within 7 days before randomization or within Days 1 to 8 of treatment
• Scheduled to receive any moderate emetic risk anticancer agents from Day 1 to 6
• Planned to receive treatment with a chemotherapy regimen including ordinary paclitaxel (with castor oil as solvent);
• Medications with potential antiemetic efficacy within 2 days before randomization;
• Began using opioids within 7 days prior to randomization or had a dose adjustment within the last 7 days.
• Systemic corticosteroid therapy or sedative antihistamines within 7 days before randomization;
• Use of palonosetron within 14 days before randomization;
• Use of NK-1 receptor antagonists within 28 days before randomization;
• Use of moderate to strong CYP3A4 inhibitors within 7 days before randomization; use of moderate to strong CYP3A4 inducers or specific CYP2D6 substrates within 28 days before randomization;
• Vomiting and/or retching and nausea within 24 hours before randomization;
• Subjects with symptomatic brain metastases, or with any symptoms suggestive of brain metastases or intracranial hypertension;
• With uncontrolled serosal effusion;
• Patients with serious cardiovascular diseases;
• Concurrent uncontrolled hypertension before randomization;
• Patients with active hepatitis B, active hepatitis C, acquired immunodeficiency syndrome (AIDS) or HIV test positive, and active syphilis test positive;

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center Yuexiu Campus

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Nausea

Interventions

Dexamethasone; Palonosetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 15, 2024
• Study Start: September 3, 2024
• Primary Completion: July 28, 2025
• Study Completion: October 3, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-10

Locations

CN (1)